Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Advanced Malignant Mesothelioma
Localized Malignant Mesothelioma
Recurrent Malignant Mesothelioma
Drug: cediranib maleate
Other: diagnostic laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma|
- Objective response rate (complete or partial response [CR or PR]) of patients with malignant mesothelioma who are treated with cediranib maleate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
- Changes in laboratory correlates [ Time Frame: Baseline, days 15 and 29 of course 1, and then every 28 days ] [ Designated as safety issue: No ]Examined using paired t-test or Wilcoxon signed-ranks test.
- Pharmacogenomics by correlating genetic polymorphisms with drug activity and toxicity (optional) [ Time Frame: Week 1 of course 1 ] [ Designated as safety issue: Yes ]Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode VEGF-A or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
|Study Start Date:||December 2005|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive oral cediranib maleate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate
Other Names:Other: diagnostic laboratory biomarker analysis
I. Determine the objective response rate in patients with malignant pleural, peritoneal, or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171 (cediranib maleate).
I. Determine the progression-free survival of patients treated with AZD2171. II. Determine the toxicity experienced by patients treated with AZD2171. III. Determine median and overall survival of patients treated with AZD2171.
I. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma.
OUTLINE: This is a multicenter study.
Patients receive oral cediranib maleate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies. After completion of study treatment, patients are followed for up to 8 weeks.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Hedy Kindler||University of Chicago Comprehensive Cancer Center|